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srilanka_63 3 posts  |  Last Activity: Aug 29, 2014 7:28 AM Member since: May 2, 2006
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  • Abstract: 4140Maintenance of normal serum K+ with ZS-9 once daily in patients with CHF: subgroup analysis of a phase 3 multicenter, randomised, double-blind, placebo-controlled trial of patients with hyperkalaemia
    Authors:
    M.A. El-Shahawy1, B. Singh2, H.S. Rasmussen3, P.T. Lavin4, A. Yang5, W. Qunibi6, 1Academic Medical Research Institute - Los Angeles - United States of America, 2Southwest Clinical Research Institute - Tempe - United States of America, 3ZS Pharma, Inc. - Coppell - United States of America, 4Boston Biostatistics Research Foundation - Framingham - United States of America, 5Xelay Acumen, Inc. - Belmont - United States of America, 6University of Texas Health Science Center at San Antonio - San Antonio - United States of America,
    Topic(s):
    Heart failure, other
    Citation:
    European Heart Journal ( 2014 ) 35 ( Abstract Supplement ), 722
    Hyperkalemia (HK) limits use of RAAS inhibitors (RAASi) in patients (pts) who derive the greatest cardiovascular or survival benefit, such as those with congestive heart failure (CHF), chronic kidney disease (CKD), or diabetes. ZS-9, a nonabsorbed cation exchanger designed to entrap potassium (K+) in the gut, significantly reduced serum K+ vs placebo (PBO) over 48 hr with excellent tolerability in pts with CKD and HK. We performed a predefined subset analysis in pts with CHF from a large phase 3 trial of ZS-9 for HK.
    Methods: Pts (N=753) with K+ 5.0-6.5 mmol/L were randomized (1:1:1:1:1) to ZS-9 (1.25g, 2.5g, 5g or 10g) or PBO orally 3X daily for 48 hr (acute phase). At the end of this phase, pts with K+ 3.5-5.0 mmol/L (n=542) were re-randomized 1:1 to the same ZS-9 dose given acutely or PBO once daily (QD) for Day 3-15 (extended phase) (if they were on ZS-9 acutely), or re-randomized to 1.25g or 2.5g ZS-9 QD (if they were on PBO acutely). RAASi were kept constant during the study. We used unpaired t-test to compare serum K+ in the subset of pts with CHF treated with the highest ZS-9 dose (10g) vs PBO.
    Results: Of 753 pts, 300 (40%) had CHF at baseline as determined by investigator, of whom 72% were on RAASi. Mean baseline K+ was 5.3 mmol/L in pts with CHF. Of the CHF pts, 204 entered the extended phase. Of these, 26 remained on 10g ZS-9 and 23 were switched to PBO. Their extended phase baseline K+ was comparable (4.4 vs 4.5 mmol/L) and similar to the overall group (4.5 [n=63] vs 4.4 [n=61] mmol/L). On Day 15, mean K+ (mmol/L) was 4.5 in CHF pts on 10g ZS-9 vs 5.0 in those switched to PBO (p=0.002; Fig. 1).
    Conclusion: 10g ZS-9 once daily maintained mean serum K+

  • srilanka_63 srilanka_63 Aug 26, 2014 3:15 PM Flag

    CONCLUSION: Conclusion: 10g ZS-9 once daily maintained mean serum K+

  • srilanka_63 srilanka_63 Aug 29, 2014 7:28 AM Flag

    The reason this is important is that Raas inhibitor therapies could be complicated by therapies which control polassium levels. Here, the researchers show that such a confounding effect does not occur. THis then means that the product should have wider market acceptance. Sri

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